Arterial Inflow and Muscle Ischemia During Calf Stimulation With the Veinoplus Device

NCT01592812 | Completed Phase 4 DMC

• 1 other identifier: 2011-A01546-35
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Stimulation of arterial inflow to the lower limb is important to obtain functional improvement in peripheral artery diseased (PAD) patients with claudication. The clinical effect of muscle stimulation to increase arterial inflow and the direct evaluation of the regional blood flow impairment (RBFI) in the area of stimulation, have not been evaluated in PAD patients. Fifteen adult patients with stable arterial claudication will participate. Recruitment will be performed among patients referred for exercise oxymetry (treadmill: 3.2km.h-1, 10% slope) After two minutes of rest, the gastrocnemius will be stimulated for 20 minutes at an increasing frequency rate with 5 min steps (1 Hz, 1.25 Hz, 1.5 Hz and 1.75 Hz) on the most symptomatic side. The investigators record the tcpo2 value, arterial blood inflow with ultrasound of the femoral artery, and near infra-red spectrometry (NIRS) on both sides. Patients will be instructed to report eventual contraction-induced pain in the stimulated calf.

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

• arterial inflow

  Ultrasound and doppler measurement of femoral inflow before, during and for 10 minutes after stimulation

  during stimulation

Study Arms (1)

electrical stimulation

EXPERIMENTAL

Evaluation of the effect of calf stimulation on flow and tissue oxygenation

Device: electrical muscle stimulation

Interventions

electrical muscle stimulation DEVICE

Duration of the stimulation 20 minutes

Also known as: Veinoplus device

electrical stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• French native
• Stable stage 2 peripheral artery disease
• Patent femoral artery on both sides
• Age \> 18 years

You may not qualify if:

• Pregnancy
• Adults protected by maw

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

University Hospital

Angers, France

Location

Related Publications (1)

• Abraham P, Mateus V, Bieuzen F, Ouedraogo N, Cisse F, Leftheriotis G. Calf muscle stimulation with the Veinoplus device results in a significant increase in lower limb inflow without generating limb ischemia or pain in patients with peripheral artery disease. J Vasc Surg. 2013 Mar;57(3):714-9. doi: 10.1016/j.jvs.2012.08.117. Epub 2013 Jan 9.

  PMID: 23312939 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Pierre Abraham, MD; PhD

  University Hospital in Angers (France)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2012
• First Posted: May 7, 2012
• Study Start: January 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 18, 2013

Record last verified: 2013-03

Locations

FR (1)